Since the discovery of AIDS in 1981, gay men in the urban areas accounted for approximately two-thirds of all AIDS cases in the United States, Europe, and Latin America. This proportion, however, is rapidly changing due to increasing numbers of heterosexual women becoming infected through sexual intercourse with infected men. According to the World Health Organization (WHO), it is anticipated that most new infections will occur in women by the year 2000. See, L. K. Altman "New York Times" Jul. 21, 1992, page C3. With the staggering increase in sexually transmitted diseases such as AIDS, there has been a resurgence of interest toward the development of reliable, convenient contraceptive/prophylactic devices to be worn by a passive sexual partner during sexual relations.
Devices which prevent undesired conception and/or exchange of bodily fluids during sexual intercourse have been known for many years. Female contraceptives are generally divided into four basic types which include orally administered pharmaceuticals; the cervical cap; devices which rely on chemical spermicides, such as diaphragms, sponges, foams, jellies, dermal implants and suppositories; and the intrauterine device. These contraceptives, however, suffer from a number of serious disadvantages.
Although effective in preventing conception, oral contraceptives reportedly have various undesirable side effects, including possible implication in carcinogenic damage to the gall bladder and liver. The diaphragm, while reliable when correctly used, is a cumbersome and inconvenient contraceptive that can easily interrupt or detract from the act of intercourse. Spermicidal contraceptives are also inconvenient to use and may be only as much as 85% reliable as a contraceptive. The cervical cap cannot be fitted on some women, and on women who are able to wear it, it may produce discomfort and infection. The intrauterine device has been the subject of much public controversy and has been reported to be unsafe under certain circumstances.
There may also be a possibility of danger to women who are susceptible to Toxic Shock Syndrome, since the cervical cap, the intrauterine device and spermicidal implants are all foreign bodies that are left inside the vaginal vault either permanently or for several hours after intercourse.
These known methods of female contraception do not provide adequate and independent protection from sexually transmitted diseases. Although spermicidal implants may provide some protection, the available female contraceptives do not provide a reliable impermeable barrier to infection vectors such as HIV.
Unlike female contraceptives, the male condom is the usual form of contraceptive available to men. It is also the most reliable protection against sexually transmitted disease that is currently available to either sex, even though the male condom may have a failure rate as high as 17%. The male condom, especially when made of latex, provides an effective membrane barrier against the transmission of infection. Additionally, the present male condom is widely available, economical, does not require a doctor's services, and does not normally cause any side effects to either partner.
The conventional male condom comprises an elongated tubular sheath made of thin, flexible material such as latex film. The sheath is closed at one end and open at the other end to provide for the insertion of a penis. The opening includes a periphery having a beaded or constricted rim. The condom is put on by rolling it onto or pulling it onto an erect penis. The latex-type condom fits tightly in order to be kept in place during intercourse.
The male condom has several disadvantages which include breakage, leakage, and slippage. After ejaculation, if the penis is left inside and continues to soften, the conventional condom may slip off, causing unwanted leakage of semen and infectious matter. Additionally, the penis must be erect in order to put on the condom, which causes an untimely interruption of the sex act. Furthermore, the loss of sensation experienced by the man may be caused by the fact that the present male condom must often be tight-fitting in order to stay in place. Because of the loss of sensation and inconvenience, men generally consider the use of condoms undesirable and there is often great resistance to their use on a regular basis.
Recent attempts have been made to design a condom or condom-like device as a contraceptive/prophylaxis devices to be worn on the inside of the passive sexual organs of a passive partner. See, U.S. Pat. Nos. 4,805,604; 4,867,176; 4,945,923; 4,976,273; and 5,074,314 for examples of such condom devices. These devices include condoms having a disposable applicators or condoms having built-in retaining elements, e.g. rings, to secure the condom within the passive sexual organ. A sampling of these attempts is described below.
U.S. Pat. No. 4,805,604 describes a receptive condom device adapted to be received by a passive sexual organ prior to intercourse. The device consists of a thin elastic membrane sheath having a closed end, a supporting ring structure at its open end, and an insertion tube adapted to deliver the condom to a passive sexual organ prior to intercourse. A charge of compressed air, in communication with the inside of the condom, forces the condom out of the tube end into the passive sexual organ closed end first. The collapsed charge and insertion tube are then removed, leaving the condom in place. While the condom device is satisfactory for its intended use, the described method of application could be improved.
U.S. Pat. No. 4,867,176 describes a female condom and a disposable tampon-like applicator device adapted to facilitate vaginal insertion. The condom is inserted into the vagina using the applicator fitted with a broad tip portion which is received in the closed distal end of the condom. The applicator is then removed, leaving the condom in place. The disadvantages of the described device is that applicator is cumbersome and may inadvertently rip or tear the condom during insertion into the vagina or pull the condom out from the vagina during removal of the applicator device.
U.S. Pat. No. 5,074,314 describes a protective sheath for use in a bodily orifice containing a inner solid retention element at the closed bottom end for retaining or securing the sheath within the orifice. The disadvantage of the described device is that the retention element may cause physical discomfort for the wearer during sexual relations. Moreover, the protective sheath does not include an applicator to properly align the retention element within the vagina.
U.S. Pat. Nos. 4,945,923 and 4,976,273 describe a vaginal sheath having flexible rings at both the top open and bottom closed ends. The bottom ring portion of the sheath is inserted into the vagina for anchoring against the cervix like a diaphragm. The disadvantages of the described devices are that they are cumbersome and difficult to fit. Moreover, it is also known that such devices are difficult to correctly insert into the vagina. See, for example, E. H. in "Mirabella," August 1992, page 70 and F. Vrazo in "New York Daily News," Jan. 22, 1990.
Accordingly, there is a need in the art for a simple and convenient condom assembly and method of application for a sexually passive partner which overcomes at least some of the aforementioned deficiencies in conventional devices.